At a glance
ClinicalIndex Comparison Record- ✓Newly diagnosed non-rhabdomyosarcoma soft tissue sarcoma (STS) confirmed by central pathology review, either metastatic or non-metastatic
- ✓Meets criteria for intermediate or malignant STS histology (adipocytic, fibroblastic/myofibroblastic, fibrohistiocytic, smooth muscle, vascular, chondro-osseous, tumors of uncertain differentiation, or malignant peripheral nerve sheath tumor)
- ✓Gross resection of primary tumor completed ≤42 days prior to enrollment, with exceptions for high-grade tumors >5 cm, tumors not grossly resectable without unacceptable morbidity, or metastatic high-grade disease
- ✓Lansky performance status 50-100% (age ≤16 years) OR Karnofsky 50-100% (age >16 years)
- ✕Tumors arising in bone
- ✕Patients with tumor recurrence after gross total resection
- ✕Prior anthracycline (doxorubicin or daunorubicin) or ifosfamide chemotherapy for patients on arms C or D
- ✕Prior radiotherapy to tumor-involved sites
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Risk-Based Treatment for Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS) in Patients Under 30 Years of Age
In Brief
A Phase 3 clinical trial evaluating doxorubicin hydrochloride, clinical observation, and 3 other interventions for Adult Alveolar Soft-part Sarcoma and 28 related conditions. Completed, enrolled 588 participants across 187 sites in 5 countries.
Detailed Summary
This phase III trial is studying observation to see how well a risk based treatment strategy works in patients with soft tissue sarcoma. In the study, patients are assigned to receive surgery +/- radiotherapy +/- chemotherapy depending on their risk of recurrence. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.
Study Details
Timeline
Interventions
Given IV
Patients undergo observation
Patients undergo surgery
Patients undergo radiotherapy
Given IV